Medi-Therm II MTA5900 Operators Manual Nov 1998

Safety Precautions

1.0 Safety Precautions

WARNING

DANGER Do not use the Medi-Therm II machine in the presence of flammable anesthetics. Risk of explosion can result.

WARNING • If the patient’s temperature is not responding or does not reach the prescribed temperature in the prescribed time or deviates from the prescribed temperature range, notify the attending physician promptly. Failure to notify the physician promptly may result in serious injury or death. • Power interruption will cause the Medi-Therm II machine to go into a standby mode, resulting in no therapy to the patient. Follow instructions for desired mode to resume operation. Failure to resume therapy could result in serious injury or death. • When performing the PROBE CHECK (p. 18, 10.1.2, item 4), use a protective sheath on the probe. Failure to use a sheath could result in cross-contamination.

• A physician’s order is required for setting blanket temperature and for continued use of equipment. At least every 20 minutes or as directed by a physician, check patient’s temperature and skin condition of areas in contact with blanket; also, check blanket water temperature. Pediatric, temperature-sensitive, and operating room patients should be checked more frequently. Failure to monitor patient may result in skin damage or inappropriate patient temperature.

• Keep the area between the patient and the blanket dry. Excessive moisture may result in skin damage. • Do not tip machine over without first draining the water out and unplugging the power cord. Damage to the machine or electrical shock can result. • Repairs should be performed by qualified personnel such as certified biomedical electronics technicians or certified clinical engineers familiar with repair practices for servicing medical devices, and in accordance with the Medi-Therm II Service Manual. Do not attempt repairs to Gaymar medical equipment unless you possess these skills. Damage to the machine or malfunction may otherwise result.

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Read and understand this operating manual and all precautions listed below prior to using the Medi-Therm II Hyper/Hypothermia Machine.

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Medi-Therm II

CAUTION • Fill with distilled water only. Failure to use distilled water may result in poor machine performance. Do not use alcohol. Alcohol may accelerate blanket deterioration. Do not operate without water, since damage to internal components may result. Do not overfill. Overfilling may result in overflow because the water in the blanket drains back into the machine when the machine is turned off. • Place a dry absorbent sheet between the patient and the blanket when using all-vinyl blankets. Moisture may accumulate which may result in skin damage.

• Avoid placing additional heat sources between the patient and blanket. Skin damage may result. • Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over boney prominences. Skin damage may result.

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YSI 400 series or equivalent patient probe

connector hose

Hyper/Hypothermia blanket

®

Medi-Therm II machine

pinch clamp

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PP

SU

LY

PP

SU

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Clik-Tite connector

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Clik-Tite connectors and representative hose clamps

Quick-disconnects on machine end

Figure 1-Medi-Therm II Hyper/Hypothermia System

2.0 Description This manual describes the operation of the Medi-Therm II Hyper/Hypothermia machine. The Medi-Therm II Hyper/Hypothermia machine provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to a Gaymar Hyper/Hypothermia blanket. The companion blanket provides the interface for heating or cooling the patient. A patient probe senses patient temperature.

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The Medi-Therm II machine, Hyper/Hypothermia blanket, connector hose, and patient probe comprise the Medi-Therm II system (fig. 1). Please read and understand the precautions on page 1 and the following operating instructions before attempting to use the Medi-Therm II system. In addition, we recommend you request in-service training from your Gaymar representative.

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control panel

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Medi-Therm II

Description

Please familiarize yourself with the location and purpose of the features (fig. 2) before reading the start-up procedures or attempting to operate the Medi-Therm II Machine.

Operator Control Panel Identifies displays, indicators, and controls used in Medi-Therm II operation (pp. 4-5).

Water Fill Opening Lift cover. Fill unit with distilled water until green band on float is fully visible (p. 7)

Patient Probe Jack Accepts patient probe plug connecting patient probe to machine (pp. 10, 12). Use YSI 400 series probe or equivalent.

Operating Instructions & Precautions Condensed instructions are located on the cover of the water fill opening and on the rear-facing side of the Operator Control Panel's sloped surface.

Blanket Connections & Probe Check Well Quick-disconnects facilitate connection to blanket water supply (p. 6). PROBE CHECK well verifies patient probe (p. 18). ON/OFF Switch (Circuit Breaker) Controls power to Medi-Therm II.

®

Figure 2-Medi-Therm II features

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3.0 Features

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Features

Medi-Therm II

Medi-Therm II

 TEMPERATURE

TO CONTROL BLANKET TEMPERATURE:

°C °F

CONNECT BLANKET(S) PRESS MANUAL BUTTON SET DESIRED BLANKET TEMP.

CHECK WATER FLOW MANUAL

CHECK PATIENT PROBE

Blanket

ADD WATER

°C/°F

TO CONTROL PATIENT TEMPERATURE:

REMOVE FROM USE NOW MACHINE SHUT DOWN

CONNECT BLANKET(S) INSERT PATIENT PROBE PRESS AUTO BUTTON SET DESIRED PATIENT TEMP.

AUTO

Patient

Set Point

TO MONITOR PATIENT TEMPERATURE: (NO THERAPY)

TEST LIGHTS

SILENCE ALARM

INSERT PATIENT PROBE PRESS MONITOR BUTTON

MONITOR

Figure 3-Medi-Therm II Control Panel

4.0 Operator Control Panel The control panel is divided into sections according to function and use. The principal panel sections are identified in figure 3.

Œ STATUS SECTION STATUS displays light to indicate both the machine’s flow status and how the blanket water temperature is being controlled to reach the desired temperature setting. STATUS displays function in both MANUAL and AUTO modes. FLOW-OK indicates blanket water is flowing adequately. HEAT indicates blanket water is being heated. The maximum blanket temperature is: • MTA5900 ... 41°C (105.8°F) • MTA5901 ... 41°C (105.8°F) • MTA5942 ... 42°C (107.6°F) IN-TEMP indicates the Medi-Therm II is controlling temperature at the desired setting. COOL indicates blanket water is being cooled. Minimum blanket temperature is 4°C (39.2°F).

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 ALERT SECTION ALERT indicators light when some form of operator action is required. In addition to the visual indicator, an audible alarm may sound. ALERT controls allow the Medi-Therm II operator to test panel lights or to silence the audible alarm. CHECK WATER FLOW indicates the flow of water to the blanket has been restricted. CHECK PATIENT PROBE indicates the patient probe is sensing an abnormal patient temperature (below 32°C [89.6°F] or above 45°C [113°F]). It may indicate the patient probe has become dislodged, an incorrect probe is being used, or a probe has become defective. An audible alarm accompanies this alert. ADD WATER indicates the water reservoir is filled to less than the recommended level. REMOVE FROM USE NOW / MACHINE SHUTDOWN indicates the Medi-Therm II has shut down due to blanket water temperature exceeding either the high or the low limit. An audible alarm accompanies this alert. Remove the Medi-Therm II machine from use immediately.

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Œ STATUS: Flow-OK Heat In-Temp Cool SELECT MODE Ž  ALERT

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Medi-Therm II

Operator Control Panel

SILENCE ALARM temporarily silences the audible alarm. The alarm will reactivate in approximately 5 minutes if the condition persists. NOTE: The SILENCE ALARM button will not function if the REMOVE FROM USE NOW / MACHINE SHUTDOWN indicator is lit.

Ž MODE SECTION The SELECT indicator lights when a choice of operating modes is required. MODE buttons select the desired operating mode. Patient therapy is provided in either MANUAL or AUTO mode. A third mode, MONITOR, may be used to monitor patient temperature without providing therapy. After the mode button is pressed, the indicator at the top of the mode button lights. MANUAL selects the manual mode of operation. In MANUAL mode, the operator must observe patient temperature and adjust the blanket water set point temperature to obtain the desired results. AUTO selects the automatic mode of operation. In AUTOMATIC mode, the operator sets the desired temperature and the patient temperature is automatically regulated to the operator specified set point.

 TEMPERATURE SECTION TEMPERATURE displays identify BLANKET, PATIENT, and SET POINT temperatures. Temperature may be set and displayed in either degrees Celsius (°C) or Fahrenheit (°F). * BLANKET indicates the actual temperature of the water being delivered to the blanket. This display is illuminated when MODE is set to either MANUAL or AUTO. PATIENT indicates actual patient temperature as sensed by the probe connected to the patient probe jack. This display is illuminated when MODE is set to MANUAL, AUTO, or MONITOR and a patient probe is plugged into the PATIENT PROBE jack. SET POINT indicates the desired SET POINT temperature. When operating in MANUAL mode, pressing the SET POINT button (“∇” or “∆”) sets the desired BLANKET water temperature. When in AUTO mode, pressing the SET POINT button sets the desired patient temperature. °C/°F displays the temperature in either degrees Celsius (°C) or Fahrenheit (°F). Pressing the °C/°F button will display the corresponding indicator. *

* Some models do not have the °C/°F feature.

MONITOR selects the monitor mode of operation. In MONITOR mode, the operator may monitor patient temperature without providing therapy.

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TEST LIGHTS confirms that all indicator lights and digital displays are working, and that the audible alarm is functioning. The displays flash and the audible alarm sounds as long as the TEST LIGHTS button is pressed.

Operator Control Panel

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Medi-Therm II

5.0 Start-up Procedure

Return

For your convenience, condensed versions of the following instructions have been permanently mounted on the cover of the water fill opening and on the rearfacing side of the Operator Control Panel's sloped surface.

T RE

T RE

N UR

N UR

T RE

LY PP SU

T RE

LY PP SU

N UR

S

N UR

Y PL UP

LY PP SU

Perform the following start-up procedure each time the Medi-Therm II system is placed in operation: Supply

5.1 Close Pinch Clamps

Figure 5-Quick-disconnects

Pinch clamps are provided on both the connector and blanket hoses to prevent water spillage when blankets are changed (fig. 4). Close the pinch clamps on the connector hose and Hyper/Hypothermia blanket.

collar to snap back into position. Check to make sure the fitting is fully engaged by tugging firmly on the hose fitting. b.

Attach the two Clik-Tite connectors (fig. 6) on the connector hose to the blanket. Insert the male fitting into the female. When fittings are fully seated, snap the locking ring into place to assure a positive lock.

Figure 4-Pinch Clamps

5.2 Attach Blanket Attach the Hyper/Hypothermia blanket to the Medi-Therm II machine (fig. 1): a.

Connect a Gaymar Model DBK9 connector hose to the Medi-Therm II machine. The hose is ten feet long. It has quick-disconnect (metal) fittings for the Medi-Therm II machine end and Clik-Tite® (plastic) connectors for the blanket end. To connect the hose, attach one quick-disconnect fitting to the RETURN machine connection (top) and one to the SUPPLY (bottom). See figure 5. To insure a tight connection, push the retaining collar toward the cabinet and insert the quick-disconnect fitting firmly. While holding the fitting, allow the retaining

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Figure 6-Clik-Tite Connector

5.3 Open All Pinch Clamps Open all pinch clamps on the connector hose and the Hyper/Hypothermia blanket. Failure to open the pinch clamps will prevent water flow and will trigger the CHECK WATER FLOW alert.

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Medi-Therm II

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Start-up Procedure

Start-up Procedure / Shutdown Procedure

5.4 Check Water Level

5.6

Perform Indicator Light Test

Check to make sure water is at the proper level by raising the cover on the water fill opening. Fill with distilled water until the green band on the float is fully visible (fig. 7).

Since machine indicators are essential to proper machine operation, you should test the indicator lights each time the machine is placed in operation. Perform this test by pressing and holding the TEST LIGHTS button. While holding the TEST LIGHTS button down, verify the following occurs: • the right and left halves of the display panel light alternately; • the four status legends (FLOW-OK, HEAT, IN-TEMP, and COOL) light;

CAUTION • Add distilled water only. Failure to use distilled water may result in poor machine performance. • Do not use alcohol, which may accelerate blanket deterioration. • Do not operate without water, since damage to internal components may result. • Do not overfill. Overfilling may result in overflow because the water in the blanket drains back into the machine when the machine is turned off.

5.5 Connect Power/Turn Machine On If the machine is not already plugged in, insert the power cord plug into a properly grounded AC receptacle at this time. Press the ON/OFF Switch to the ON position.

• the ALERT legend and its four (triangular) indicators light;

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Figure 7-Float, showing proper water level

• the three mode legends and SELECT heading light; • the three temperature displays (BLANKET, PATIENT, and SET POINT) indicate 888, 888.8, and 888.8, respectively; • the two temperature control legends (“°C” and “°F”) * and the two lines connecting SET POINT to both the BLANKET and PATIENT display light; • the audible alarm sounds. If any indicator does not light, or the alarm does not sound, remove the machine from use. This completes the start-up procedures for the Medi-Therm II machine. Please proceed to sections 7.0 through 7.3 for the operating instructions for MANUAL, AUTO and MONITOR modes.

6.0 Shutdown Procedure When first turned on, the Medi-Therm II enters its standby mode: • the ON/OFF switch will light;

When therapy is completed, turn off the Medi-Therm II machine. Close pinch clamps before disconnecting the blanket.

• the machine will beep once; • the SELECT heading will light; • the BLANKET, PATIENT, and SET POINT temperature displays will show dashes; and

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Medi-Therm II

* Some models do not have the °C/°F feature.

• the “°C” or “°F” indicator will light, depending on the scale last selected. * NOTE: If the ADD WATER indicator lights, add distilled water until the green band on the float is visible.

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Read and understand the contents of these Operating Instructions and associated precautions before using the Medi-Therm II machine. Any application of the Hyper/ Hypothermia System must be under the direction of the attending physician.

WARNING • If the patient's temperature is not responding or does not reach the prescribed temperature in the prescribed time or deviates from the prescribed temperature range, notify the attending physician promptly. Failure to notify the physician promptly may result in serious injury or death. • Power interruption will cause the Medi-Therm II machine to go into a standby mode (see item 5.5, p. 7), resulting in no therapy to the patient. Follow instructions for desired mode to resume operation. Failure to resume therapy could result in serious injury or death.

7.1 Manual Mode (To Control Patient Temperature) When operating in the MANUAL mode, the Medi-Therm II machine regulates the BLANKET water temperature to the selected SET POINT. A temperature sensor within the machine monitors water temperature, and the machine heats or cools the blanket water as required to bring it to the SET POINT temperature. In MANUAL mode, the operator must observe the patient’s temperature and manually adjust the blanket temperature to obtain the desired results. To operate in MANUAL mode:

 Perform all start-up procedures (pp. 6-7).  Press the MANUAL mode button. The upper window on the MANUAL button will light.

The BLANKET display will indicate blanket water temperature. The SET POINT display will indicate the default temperature (32°C [89.6°F]) at startup, until selecting the SET POINT temperature in step 4 below.

Ž If desired, change the temperature scale by pressing the “°C/°F” button. *

The Medi-Therm II machine is designed to operate in three (3) modes: • MANUAL (blanket temperature control), • AUTO (automatic patient temperature control), and • MONITOR (patient temperature monitoring). Some applications may require a second blanket in order to achieve additional or more rapid heating or cooling. For these situations, a second blanket may be connected to the machine. The rate of patient heating or cooling may also be increased by positioning half- and full-size blankets so that greater body surface is in contact with the blankets. NOTE: When connecting a second blanket to the Medi-Therm II machine, check the water level (see Start-up Procedure, pp. 6-7) prior to connecting the additional blanket.

the SET POINT display to the prescribed  Adjust blanket temperature setting by pressing the “∇” or “∆” button to decrease or increase the SET POINT. The STATUS display will indicate HEAT or COOL while the machine is heating or cooling the blanket water. When the blanket temperature stabilizes (within 1°C [1.8°F] of the SET POINT temperature), the IN-TEMP indicator will light indicating that the desired blanket water temperature is being maintained. NOTE: When the Medi-Therm II machine is turned on, the machine set point defaults to 32°C (89.6°F) when MANUAL mode is selected, or 37°C (98.6°F) when AUTO mode is selected. Once a SET POINT temperature for a mode has been selected, it is retained for that mode until the SET POINT temperature is changed or the machine has been turned off. The SET POINT temperature in one mode does not affect the SET POINT temperature in another mode. * Some models do not have the °C/°F feature.

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7.0 Modes of Operation

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Medi-Therm II

Modes of Operation / Manual Mode

Modes of Operation / Manual Mode

Medi-Therm II Flow-OK

Heat

ALERT

In-Temp SELECT

Cool

MODE

 TEMPERATURE

TO CONTROL BLANKET TEMPERATURE:

CHECK WATER FLOW MANUAL



CHECK PATIENT PROBE

Blanket

ADD WATER TO CONTROL PATIENT TEMPERATURE:

REMOVE FROM USE NOW MACHINE SHUT DOWN

AUTO

CONNECT BLANKET(S) INSERT PATIENT PROBE PRESS AUTO BUTTON SET DESIRED PATIENT TEMP.

TO MONITOR PATIENT TEMPERATURE: (NO THERAPY)

TEST LIGHTS

SILENCE ALARM

MONITOR

°C °F

CONNECT BLANKET(S) PRESS MANUAL BUTTON SET DESIRED BLANKET TEMP.

INSERT PATIENT PROBE PRESS MONITOR BUTTON

Patient

Ž °C/°F Set Point

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STATUS:



Figure 8-Manual Mode

WARNING



At least every 20 minutes, or as directed by a physician, check the patient’s temperature and skin condition of areas in contact with blanket; also check BLANKET WATER temperature display. Failure to monitor patient may result in skin damage or inappropriate patient temperature.

NOTE: While operating in the MANUAL mode, the patient probe may be used to monitor the patient’s temperature. To use this Medi-Therm II feature, insert sensing end of patient probe into patient and tape

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Medi-Therm II

securely to prevent accidental dislodgment. Insert plug end of patient probe into PATIENT PROBE jack. Make sure probe plug is fully seated. The MANUAL mode switch must be pressed. Use YSI 400 Series Probes or equivalent. If in doubt that the correct probe is being used and is operating properly, perform a PROBE CHECK test (p. 18, 10.1.2, item 4). Patient temperature will be indicated on the PATIENT temperature display. If the patient probe senses an abnormal patient temperature (below 32°C [89.6°F] or above 45°C [113°F]), the CHECK PATIENT PROBE alert will light and an audible alarm will sound. This condition may indicate the patient probe has become dislodged, an incorrect probe is being used, or the probe has become defective (see Alerts, pp. 18-19).

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Medi-Therm II

Medi-Therm II Flow-OK

Heat

ALERT

In-Temp SELECT

Cool

MODE

’ TEMPERATURE

TO CONTROL BLANKET TEMPERATURE:

°C °F

CONNECT BLANKET(S) PRESS MANUAL BUTTON SET DESIRED BLANKET TEMP.

CHECK WATER FLOW MANUAL

CHECK PATIENT PROBE

Blanket

ADD WATER

°C/°F

TO CONTROL PATIENT TEMPERATURE:

REMOVE FROM USE NOW MACHINE SHUT DOWN

AUTO

 Patient

CONNECT BLANKET(S) INSERT PATIENT PROBE PRESS AUTO BUTTON SET DESIRED PATIENT TEMP.

Set Point



TO MONITOR PATIENT TEMPERATURE: (NO THERAPY)

TEST LIGHTS

SILENCE ALARM

MONITOR

‘

INSERT PATIENT PROBE PRESS MONITOR BUTTON

Figure 9-Automatic Mode

7.2 Automatic Mode (To Control Patient Temperature) When operating in the AUTO mode, the Medi-Therm II automatically regulates the patient’s temperature to the selected SET POINT. The machine constantly compares actual patient temperature with the SET POINT value, and automatically adjusts the BLANKET water temperature so that the desired patient temperature is achieved. To operate in AUTO mode:

 Perform all start-up procedures (pp. 6-7). sensing end of patient probe into patient ‚ Insert and tape securely to prevent accidental dislodgment. Insert plug end of patient probe into PATIENT Ž PROBE jack. NOTE: Make sure probe plug is fully seated. Use YSI 400 series probes or equivalent. If in doubt that the correct probe is being used and is operating properly, perform a PROBE CHECK test (p. 18, 10.1.2, item 4). 10

Ž the AUTO mode button. The upper  Press window on the AUTO button will light. NOTE: To prevent accidental triggering of the CHECK PATIENT PROBE alert, place probe in patient and wait five (5) minutes before pressing AUTO mode button. The BLANKET display will indicate blanket water temperature. The PATIENT display will indicate patient temperature. The SET POINT temperature will indicate the default temperature (37°C [98.6°F]) at start-up, until selecting the SET POINT temperature in step 6 (p. 11). desired, change the temperature scale by  Ifpressing the “°C/°F” button. *

* Some models do not have the °C/°F feature.

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STATUS:

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Modes of Operation / Automatic Mode

Modes of Operation / Automatic Mode

‘ Adjust the SET POINT display to the prescribed

patient temperature setting by pressing the “∇” or “∆” button to decrease or increase the SET POINT. NOTE: When the Medi-Therm II machine is turned on, the machine set point defaults to 32°C (89.6°F) when MANUAL mode is selected or 37°C (98.6°F) when AUTO mode is selected.

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Once a SET POINT temperature for a mode has been selected, it is retained for that mode until the SET POINT temperature is changed or the machine has been turned off. The SET POINT temperature in one mode does not affect the SET POINT temperature in another mode.

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Medi-Therm II

WARNING least every 20 minutes, or as directed by a ’ • At physician, check the patient’s temperature and skin condition of areas in contact with blanket; also check BLANKET WATER temperature display. Failure to monitor patient may result in skin damage or inappropriate patient temperature. • If the patient probe senses an abnormal patient temperature (below 32°C [89.6°F] or above 45°C [113°F]), therapy will stop, the CHECK PATIENT PROBE alert will light and an audible alarm will sound. This condition may indicate the patient probe has become dislodged, an incorrect probe is being used, or the probe has become defective (see Alerts, pp. 18-19).

NOTE: The PATIENT temperature display will flash when the patient’s temperature is more than 1°C (1.8°F) from the SET POINT temperature. Such flashing occurs only in the AUTO mode.

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Medi-Therm II STATUS:

Flow-OK

Heat

ALERT

In-Temp

Cool

MODE

TEMPERATURE

TO CONTROL BLANKET TEMPERATURE:

°C °F

SELECT

CHECK WATER FLOW MANUAL

CONNECT BLANKET(S) PRESS MANUAL BUTTON SET DESIRED BLANKET TEMP.

CHECK PATIENT PROBE

Blanket

ADD WATER

°C/°F

TO CONTROL PATIENT TEMPERATURE:

REMOVE FROM USE NOW MACHINE SHUT DOWN

AUTO

CONNECT BLANKET(S) INSERT PATIENT PROBE PRESS AUTO BUTTON SET DESIRED PATIENT TEMP.

Set Point

TO MONITOR PATIENT TEMPERATURE: (NO THERAPY)

TEST LIGHTS

SILENCE ALARM

MONITOR



INSERT PATIENT PROBE PRESS MONITOR BUTTON



Figure 10-Monitor Mode

7.3 Monitor Mode (Patient Temperature Monitoring, No Therapy) Press MONITOR mode when no patient temperature therapy is required, but monitoring of patient temperature is desired. To operate in MONITOR mode: steps 5.4, 5.5, and 5.6 of the Start-up  Perform Procedure (pp. 6-7).

‚ Insert sensing end of patient probe into patient and tape securely to prevent accidental dislodgment. plug end of patient probe into the Ž Insert PATIENT PROBE jack. Make sure probe plug is fully seated. Use YSI 400 Series Probes or equivalent. If in doubt that the correct probe is being used and is operating properly, perform a PROBE CHECK test (p. 18, 10.1.2, item 4). 12

Patient

Ž

 Press the MONITOR mode button. The upper

window on the MONITOR button will light. The patient’s temperature will be displayed.

desired, change the temperature scale by  Ifpressing the “°C/°F” button. * NOTE: If the patient probe senses an abnormal patient temperature (below 32°C [89.6°F] or above 45°C [113°F]), the CHECK PATIENT PROBE alert will light and sound an audible alarm. This condition may indicate the patient probe has become dislodged, an incorrect probe is being used, or a probe has become defective (see Alerts, pp. 18-19). REMEMBER . . . in MONITOR mode, no therapy is provided. * Some models do not have the °C/°F feature.

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Medi-Therm II

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Modes of Operation / Monitor Mode

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Medi-Therm II

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WARNING

Use the Medi-Therm II Hyper/Hypothermia machine only under the direction of a physician. Review the following precautions and procedures prior to each application:

DANGER Do not use the Medi-Therm II machine in the presence of flammable anesthetics. Risk of explosion can result.

WARNING • If the patient’s temperature is not responding or does not reach the prescribed temperature in the prescribed time or deviates from the prescribed temperature range, notify the attending physician promptly. Failure to notify the physician promptly may result in serious injury or death. • Power interruption will cause the Medi-Therm II machine to go into a standby mode, resulting in no therapy to the patient. Follow instructions for desired mode to resume operation. Failure to resume therapy could result in serious injury or death. • The Medi-Therm II machine is provided with a means of checking rectal/esophageal temperature probes. When performing the PROBE CHECK (p. 18, 10.1.2, item 4), use a disposable protective sheath on the probe. Failure to use sheath could result in cross-contamination. (continued next column)

• A physician’s order is required for setting blanket temperature and for continued use of equipment. At least every 20 minutes, or as directed by a physician, check patient’s temperature and skin condition of areas in contact with blanket; also, check blanket water temperature. Pediatric, temperature-sensitive and operating room patients should be checked more frequently. Failure to monitor patient may result in skin damage or inappropriate patient temperature. PEDIATRICS - The temperatures of infants and children are more responsive to surface heating and cooling than adults. The smaller the patient, the more pronounced the effect because of their higher ratio of skin contact area to body mass. TEMPERATURE-SENSITIVE PATIENTS Patients with impaired peripheral blood circulation caused by vascular diseases and patients who are incapacitated may be more sensitive to temperature changes than patients with more normal circulation. OPERATING ROOM PATIENTS - Patients with poor circulation associated with inadequate heart function, reduction in blood volume, and constriction of peripheral blood vessels may deviate from the normal response to the external application of heat and cold. • Avoid placing additional heat sources between the patient and blanket. Skin damage can result. Heat applied by the blanket can result in a rise in skin temperature at the areas of contact. The additional heat rise due to electrosurgical currents flowing to the dispersive electrode could be sufficient to cause tissue injury. Each thermal effect by itself may be completely safe, but the additive effect may be injurious.1 Keep additional heat sources from between the patient and the blanket. (continued next page)

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8.0 Patient Safety

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Medi-Therm II

Patient Safety

• Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over boney prominences.

REFERENCES 1

Gendron, F. G. Unexplained Patient Burns. Chap. 5, p. 87, Quest Publishing Co., 1988.

2

Scott, Stewart M. Thermal Blanket Injury in the Operating Room. Arch. Surg.,Vol. 94, p. 181, Feb. 1967; Crino, Marjanne H. Thermal Burns Caused by Warming Blankets in the Operating Room. Clinical Workshop, Vol. 29, pp. 149-150, Jan-Feb 1980; Gendron, Francis G. Journal of Clinical Engineering. Vol. 5, No. 1, pp. 19-26, JanuaryMarch 1980; Moritz, A.R. and Henriques, Jr., "F.C. Studies of Thermal Injury II." In The Relative Importance of Time and Surface Temperature in the Causation of Cutaneous Burns. Am. J. Path., 23:695, 1947; Stoll, Alice M. and Chianta, Maria A. Method and Rating System for Evaluation of Thermal Protection. Aerospace Medicine,Vol. 40, No. 11, pp. 1232-1238, Nov. 1969; Stewart, T. P. and Magnano, S. Burns or Pressure Ulcers in the Surgical Patient. Decubitus, Vol. 1, pp. 36-40, 1988.

3

Llorens, Alfred S. Reaction to Povidone-Iodine Surgical Scrub, Scrub Associated with Radical Pelvic Operation. Am. J. Obstet. Gynecol., pp. 834-835, Nov. 14, 1974; Hodgkinson, Darryl J., Irons, George B. and Williams, Tiffany J. Chemical Burns and Skin Preparation Solutions. Surgery, Gynecology & Obstetrics, Vol. 17, pp. 534-536, Oct. 1978.

Skin damage may result. Localized skin injury due to tissue compressed between boney prominences and fluid filled channels has occurred during prolonged cardiovascular procedures at blanket temperatures well below the scientifically established epidermal burn injury threshold.2 Local ischemia can follow the application of pressures exceeding capillary pressure resulting in tissue necrosis. This local effect may be enhanced by generalized impairment of the circulation, local shearing forces and increased metabolic demand because of temperature elevation. Pathological changes may begin in two (2) hours. • Keep the area between the patient and the blanket dry. Excessive moisture may result in skin damage. The application of heating or cooling may affect the toxicity of solutions. Prep solutions have been reported to injure the skin when allowed to remain between patients and water circulating heating blankets during prolonged procedures.3

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WARNING

Patient Safety

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Medi-Therm II

CAUTION • Place a dry absorbent sheet between the patient and the blanket when using all-vinyl blankets. Moisture may accumulate which may result in skin damage. A dry absorbent sheet placed between the patient and the Hyper/Hypothermia Blanket will provide a sanitary barrier and absorb perspiration. It will also promote more uniform distribution of heat. Vinyl blankets with nonwoven fabric surfaces do not require an absorbent sheet when using the nonwoven side.

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NOTE:

As with any precision equipment, proper care and maintenance will insure proper performance and reliability. The following routine maintenance procedures will help insure dependable Medi-Therm II operation.

• The Medi-Therm II control panel and top surfaces can be cleaned with a soft cloth lightly dampened with isopropyl alcohol.

9.1 Machine Care WARNING Do not tip machine over without first draining the water out and unplugging the power cord. Damage to the machine or electrical shock can result.

CAUTION • Add distilled water only. • Failure to use distilled water may result in poor machine performance. • Do not use alcohol. Alcohol may accelerate blanket deterioration. Alcohol is flammable.

• Clean up any accidental spills immediately-use a cloth lightly dampened with isopropyl alcohol. • You may check for clarity of fluid by viewing water flowing through clear vinyl blanket.

9.2 Blanket Care • Allow the blanket to remain connected to the Medi-Therm II machine for about 10 minutes after the machine has been turned off. This will allow most of the water to drain back into the machine. • Standard blankets should be cleaned with a damp cloth and mild detergent. If blankets must be sterilized, use any cold sterilization means, except alcohol. Exposure to harsh chemicals will cause blankets to lose flexibility and reduce their resistance to cracking.

• Do not operate without water, since damage to internal components may result.

• When storing standard blankets, they should be rolled loosely. (Do not allow to freeze.) Singlepatient use blankets should be discarded after use.

• Do not overfill. Overfilling may result in overflow because the water in the blanket drains back into the machine when the machine is turned off.

• Standard blankets can often be repaired using a vinyl patch kit. Do not return blankets to factory for repair.

• When filling an empty Medi-Therm II machine, add a small amount of germicidal or sanitizer solution to the water (MTA33 liquid, or equivalent). Carefully follow manufacturer’s recommended concentration to prevent algae growth within the Medi-Therm II system and Hyper/Hypothermia blanket.

9.3 Probe Care

Do not use too much concentrate, since it will result in “foaming,” which can reduce the blanket efficiency and may damage the circulating pump. • Do not use bleach. Bleach will damage the heating element, which could result in excessive leakage.

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• Do not autoclave. If probe must be sterilized, use any cold sterilization means except alcohol, which may accelerate probe deterioration. Always wipe dry. • Reusable probes may be cleaned with a damp cloth and mild detergent. Always wipe dry. Exposure to harsh chemicals will cause probe to lose flexibility and resistance to cracking. • Disposable probes should be discarded after use.

P/N 10484-000 11/98

9.0 Care of Medi-Therm II

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Medi-Therm II

Care of Medi-Therm II

9.4 Probe Check Well Care

9.5 Quick Disconnects

The PROBE CHECK WELL should be cleaned with a small tubular brush and detergent, and then wiped with a commercial disinfectant.

The quick-disconnects joining the connector hose to the machine may become difficult to engage. This problem can be eliminated by applying a silicone base or light machine oil to the outside of the male connector prior to engagement.

DANGER When performing the PROBE CHECK, use a protective sheath on the probe. (Becton-Dickinson catalog 3700 oral sheath or equivalent. Failure to use a sheath could result in cross-contamination.

9.6 Draining Machine It is not necessary to drain the Medi-Therm II machine after each use. However, periodic draining is recommended at least once a month. To lower the water level, close both pinch clamps on the connector hose. Place the end with both Clik-Tite connectors into a sink or pail. Open the pinch clamp. Press the ON/OFF switch to ON and press MANUAL mode button. The machine will pump the water reservoir empty. Press ON/OFF button to OFF when CHECK WATER FLOW lights. After the water is pumped out, do not leave the machine on or it may overheat. Preventive maintenance and service procedures are described in the Medi-Therm II Service Manual. These procedures should be performed by qualified personnel such as certified biomedical electronics technicians or certified clinical engineers.

Figure 11-Probe Check Well

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P/N 10484-000 11/98

Care of Medi-Therm II

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Medi-Therm II

10.1.2 Check Patient Probe

Most Medi-Therm II operating problems are minor and can be corrected by the operator. The following are alerts and troubleshooting details.

Indicates that the patient probe is sensing below 32°C (89.6°F) or above 45°C (113°F), and is not a normal patient temperature.

WARNING

WARNING Repairs should be performed by qualified personnel such as certified biomedical electronics technicians or certified clinical engineers familiar with repair practices for servicing medical devices, in accordance with the Medi-Therm II Service Manual. Do not attempt repairs to the Medi-Therm II machine unless you possess these skills. Damage to the machine, malfunction, or electrical shock may otherwise result.

If CHECK PATIENT PROBE light comes on, therapy will stop (in AUTO mode only), status lights will go out, and no additional heating or cooling will occur until the problem is corrected.

1.

CHECK PATIENT PROBE audible alarm can be silenced for five minutes while diagnosing problem by pressing SILENCE ALARM.

2.

CHECK PATIENT PROBE alert may sound if machine is placed in MANUAL, AUTO, or MONITOR mode before patient probe has been inserted in patient, since probe will be sensing room temperature. Place probe in patient and wait five (5) minutes before pressing MANUAL, AUTO, or MONITOR mode button.

3.

Check probe to make sure it has not become dislodged from patient. Reinsert and tape securely if required. Wait five (5) minutes before pressing AUTO mode button.

4.

Perform PROBE CHECK:

10.1 Alerts The Medi-Therm II machine has both visual and audible alert indicators to help you identify machine or operator caused problems. An explanation of these signals and their probable causes follow. Perform corrective action in the sequence listed.

10.1.1 Check Water Flow Circulation of water through the blanket has been restricted. Air bubbles in the blanket may remain stationary although water is flowing; a few bubbles do not adversely affect operation of the blanket.

a.

To locate and correct the source of low flow: 1.

Check that all pinch clamps are fully open.

3.

Check that hoses are not kinked or pinched off. Make sure blanket is flat and not creased. If a blanket is used with patient in sitting position, flow may be pinched off.

4.

Confirm that water supply is at proper level.

5.

Turn off machine. Close all pinch clamps. Disconnect blanket from connector hose. Direct connector hoses into water fill opening, start machine, and select MANUAL or AUTO mode. Open connector pinch clamps. If there is still no flow, turn machine off and remove from use.

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WARNING

Check that hoses are fully inserted and seated into one RETURN (top) and one SUPPLY (bottom) connector on the machine. (See Start-up Procedure, p. 6.)

2.

Insert probe into protective sheath and then into PROBE CHECK WELL on front of machine base (fig. 11).

When performing the PROBE CHECK, use a protective sheath on the probe. Failure to use a sheath could result in cross-contamination.

b.

Operate machine in MANUAL mode with a blanket connected. Adjust SET POINT temperature to between 33°C (91.4°F) and 37°C (98.6°F). Wait until machine temperature stabilizes (IN-TEMP lights and patient temperature display stabilizes). Blanket and patient temperature displays should read within 2°C (3.6°F) of each

P/N 10484-000 11/98

10.0 Alerts/ Troubleshooting

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Alerts / Troubleshooting

c.

If probe appears defective, try another probe and repeat PROBE CHECK. If a new, correct probe does not meet this test, remove machine from use and notify your medical equipment repair department.

10.2 Troubleshooting 10.2.1 Blanket Will Not Heat 1.

Check that water is circulating through the blanket. If there is no circulation, the CHECK WATER FLOW alert should light. If CHECK WATER FLOW is lit, refer to Alerts section (pp. 18-19) for corrective measures. Do not fold blankets.

2.

Check that the temperature control is operating by pressing the MANUAL mode button and then adjusting the SET POINT temperature to at least 2°C (3.6°F) above the indicated blanket temperature. This should cause the HEAT indicator to light.

10.1.3 Add Water Check to make sure water is at the proper level by raising the cover on the water fill opening. If green band on float is not visible, fill with distilled water until the green band is visible (fig. 7). If green band on float is visible, do not add water-remove machine from use and notify your medical equipment repair department.

10.2.2 Blanket Will Not Cool 1.

Check to see if water is circulating through the blanket. If there is no circulation to the blanket, the CHECK WATER FLOW alert should light. If CHECK WATER FLOW is lit, refer to Alerts section (pp. 18-19) for corrective measures. Do not fold blankets.

2.

Check that rear and side air vents are not blocked. Inlet and exhaust grills should be kept clear and clean to allow air to circulate freely.

3.

Check that the temperature control is operating by changing the SET POINT temperature to at least 2°C (3.6°F) below the indicated blanket temperature. This should cause the COOL indicator to light.

CAUTION • Add distilled water only. Failure to use distilled water may result in poor machine performance. • Do not use alcohol. Alcohol may accelerate blanket deterioration. • Do not operate without water. Damage to internal components may result. • Do not overfill. Overfilling may result in overflow because the water in the blanket drains back into the machine when the machine is turned off.

10.1.4 Remove From Use Now Machine Shutdown This alert indicates that the machine has shut down due to the blanket water temperature exceeding the high or low limit, or if a system error is detected. Remove machine from use immediately. Notify your medical equipment repair department.

10.2.3 Machine Will Not Turn On 1.

Make sure the power cord is plugged in.

2.

Reset the ON/OFF switch (circuit breaker) by turning it first off, then on.

3.

If the machine still does not turn on, remove machine from service and notify your medical equipment repair department.

10.2.4 On/Off Switch Is Turned On, But Control Panel Is Dark And No Operating Sound Is Coming From Machine Remove machine from use and notify your medical equipment repair department.

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P/N 10484-000 11/98

other. If not, patient probe may be defective or incorrect probe is being used. Use only YSI 400 Series probes or equivalent.

Alerts / Troubleshooting

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